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The purpose of this study is to evaluate the potential difference between pharmacokinetics (PK), safety, tolerability and device performance between the AZD8630 test formulation and the AZD8630 reference formulation.
This is a randomized, open-label, 2- treatment, 2- period study with a duration of approximately 6 weeks.
The Study will comprise of:
Participants will be randomized 1:1 to either Sequence 1 or Sequence 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 (Treatment A- Treatment B) | Experimental | Participants will receive Treatment A (AZD8630 Monodose inhalation powder) crossover to Treatment B (AZD8630 test inhalation powder) |
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| Sequence 2 (Treatment B- Treatment A) | Experimental | Participants will receive Treatment B (AZD8630 test inhalation powder) crossover to Treatment A (AZD8630 Monodose inhalation powder) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD8630 (test formulation) via test inhaler | Drug | Participants will receive AZD8630 via test inhaler. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum concentration-time curve from time zero to the last quantifiable concentration test/Monodose | To evaluate the relative bioavailability of AZD8630 test device compared to AZD8630 Monodose device. | From Baseline Day 1 to Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plama (peak) drug concentration (Cmax) | To evaluate the Cmax of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation. | From Baseline Day 1 to Day 11 |
| Area under the plasma concentration curve from zero to infinity (AUCinf) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Baltimore | Maryland | 21225 | United States |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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This is an open-label, 2-period cross over study.
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| AZD8630 (reference formulation) via Monodose inhaler | Drug | Participants will receive AZD8630 via Monodose inhaler. |
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| Test inhaler | Device | Participants will receive AZD8630 via test inhaler. |
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| Monodose inhaler | Device | Participants will receive AZD8630 via Monodose inhaler. |
|
To evaluate the AUCinf of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation. |
| From Baseline Day 1 to Day 11 |
| Area under the plasma concentration curve from zero to last quantifiable concentration (AUClast) | To evaluate the AUClast of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation. | From Baseline Day 1 to Day 11 |
| Time to reach peak or maximum observed concentration or response following drug administration (tmax) | To evaluate the tmax of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation. | From Baseline Day 1 to Day 11 |
| The last time point at which the concentration is measured (tlast) | To evaluate the tlast of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation. | From Baseline Day 1 to Day 11 |
| Typical elimination rate constant (λz) | To evaluate the λz of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation. | From Baseline Day 1 to Day 11 |
| Half-life associated with terminal slope of a semi-logarithmic concentration time curve (t½λz) | To evaluate the t½λz of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation. | From Baseline Day 1 to Day 11 |
| Area under the plasma concentration curve from zero to 24 (AUC [0-24]) | To evaluate the AUC (0-24) of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation. | From Baseline Day 1 to Day 11 |
| Area under the plasma concentrationcurve from zero to 24, divided by dose (AUC [0-24]/D) | To evaluate the (AUC [0-24]/D) of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation. | From Baseline Day 1 to Day 11 |
| Area under the plasma concentration curve from zero to infinity, divided by dose (AUCinf/D) | To evaluate the AUCinf/D of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation. | From Baseline Day 1 to Day 11 |
| Extrapolated area under the curve from tlast to infinity, expressed as percentage of AUCinf (%AUCextr) | To evaluate the %AUCextr of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation. | From Baseline Day 1 to Day 11 |
| Maximum observed plama (peak) drugconcentration, by dose (Cmax/D) | To evaluate the Cmax/D of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation. | From Baseline Day 1 to Day 11 |
| Apparent total body clearence of drugfrom plasma after extravascularadministration (CL/F) | To evaluate the CL/F of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation. | From Baseline Day 1 to Day 11 |
| Volume of distribution (apparent) at steady state following extravascularadministration based on terminalphase (Vz/F) | To evaluate the Vz/F of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation. | From Baseline Day 1 to Day 11 |
| Number of participants with adverse event (AEs) | To further assess the safety and tolerability following single inhaled administration of AZD8630 test formulation and AZD8630 Monodose formulation in healthy participants. | From Screening (Day -28) to Follow-up visit (7 days post last dose of AZD8630) |
| Number of AEs and SAEs associated with test device | To assess the safety and performance of the test device. | From Baseline Day 1 to Day 11 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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